MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP HOOK PLATE/ SCREWS; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Non-union Bone Fracture (2369); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: takahashi, h.Et al (2023), hook plate fixation versus locking plate fixation for distal clavicle fracture: a multicenter propensity score-matched study, nagoya j.Med.Sci.Vol.85, pages 223¿232 (japan).The purpose of this multicenter study was to compare 1) the clinical outcomes of hook plate fixation to those of locking plate fixation for distal clavicle fracture, 2) bone union with the two devices, and 3) the incidence of complications.Between 2014 to 2018, a total of 98 patients (87 male and 11 female) with a mean age of 44.65 years were included in the study.These patients had distal clavicle fractures and underwent surgery.The patients were divided into two groups according to the fixation used for treatment.Group l (lcp (depuy synthes) or variax (stryker) plate) consisting of 49 patients (44 male and 5 female), and a mean age of 43.4 years.Group h (an lcp hook plate (depuy synthes) plate) with 49 patients (43 male and 6 female), and a mean age of 45.9 years.The follow up period for group l and group h are 12.9 months and 9 months, respectively.The following complications were reported as follows: group l: 4 patients had infection, 1 patient had screw backout, and 2 patients had re-operation.Group h: 4 patients had impingement, 3 patients had infection, 1 patient had scar problem, 3 patients had nonunion, 9 patients had plate migration, 2 patients screw backout, and 1 patient had re-operation.This report is for an unknown synthes lcp, and unknown synthes lcp hook plate.This is report 3 of 5 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D1, d2a, d2b, d3, d4, g4 - 510k: this report is for an unknown constructs: lcp hook plate/ screws /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: (b)(6).H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - CONSTRUCTS: LCP HOOK PLATE/ SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18873870
• MDR Text Key: 337307135
• Report Number: 8030965-2024-03451
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention